Special Drug Use Surveillance of Vonoprazan for Maintenance Therapy of Reflux Esophagitis: Long-term Use

Conditions

Reflux Esophagitis

Brief summary

The purpose of this survey is to evaluate the safety and effectiveness of long-term administration of vonoprazan tablets when used as maintenance therapy for reflux esophagitis in routine clinical settings.

Detailed description

The drug being tested in this survey is called vonoprazan. Vonoprazan is being tested to treat patients who have reflux esophagitis. This survey will look at the safety and effectiveness of long-term administration of vonoprazan tablets when used as maintenance therapy for reflux esophagitis in routine clinical settings. The survey will enroll approximately 1000 participants. \- Vonoprazan 10 mg or 20 mg This multi-center observational trial will be conducted in Japan.

Manabe N, Matsuo M, Suzuki C.

2026-04-15

10.1080/14740338.2026.2612982

Interventions

DRUGVonoprazan

Vonoprazan tablets

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

No

Inclusion criteria

\- Participants who require maintenance therapy for relapsed/recurrent reflux esophagitis

Exclusion criteria

* Participants meeting the criteria of grade A to D according to the Los Angeles classification (Hoshihara's modification), by means of endoscopy at the initiation of maintenance therapy with vonoprazan tablets * Participants with a previous history of hypersensitivity to ingredients in vonoprazan tablets * Participants taking atazanavir sulfate or rilpivirine hydrochloride

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Participants Who Had One or More Adverse Drug Reactions	Up to 12 months	An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to administered drug.

Secondary

Measure	Time frame	Description
Number of Participants With Recorded Severity of Subjective Symptoms of Heartburn	Baseline, Month 6 and at Month 12	Presence or absence and severity of subjective symptoms were collected from participants during medical interviews of each visit as none (asymptomatic), mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), severe (unendurably symptomatic), and unknown. Number of participants who had mild, moderate, or severe heartburn at each time points were reported.
Number of Participants With Recorded Severity of Subjective Symptoms of Acid Reflux	Baseline, Month 6 and at Month 12	Presence or absence and severity of subjective symptoms were collected from participants during medical interviews of each visit as none (asymptomatic), mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), severe (unendurably symptomatic), and unknown. Number of participants who had mild, moderate, or severe acid reflux at each time points were reported.
Number of Participants With Recorded Severity of Subjective Symptoms of Postprandial Fullness	Baseline, Month 6 and at Month 12	Presence or absence and severity of subjective symptoms were collected from participants during medical interviews of each visit as none (asymptomatic), mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), severe (unendurably symptomatic), and unknown. Number of participants who had mild, moderate, or severe postprandial fullness at each time points were reported.
Number of Participants With Recorded Severity of Subjective Symptoms of Early Satiation	Baseline, Month 6 and at Month 12	Presence or absence and severity of subjective symptoms were collected from participants during medical interviews of each visit as none (asymptomatic), mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), severe (unendurably symptomatic), and unknown. Number of participants who had mild, moderate, or severe early satiation at each time points were reported.
Number of Participants With Recorded Severity of Subjective Symptoms of Epigastric Pain	Baseline, Month 6 and at Month 12	Presence or absence and severity of subjective symptoms were collected from participants during medical interviews of each visit as none (asymptomatic), mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), severe (unendurably symptomatic), and unknown. Number of participants who had mild, moderate, or severe epigastric pain at each time points were reported.
Endoscopic Relapse Rate	From the initiation of the maintenance therapy to Month 12 (or discontinuation of the therapy), up to 12 months	Endoscopic relapse rate was defined as a percentage of participants who met the criteria of Grade A to D in the modified Los Angeles (LA) classification. The modified LA classification graded endoscopic findings as follows- Grade N: normal mucosa; Grade M: minimal changes to the mucosa, such as erythema and/or whitish turbidity; Grade A: non-confluent mucosal breaks \<5 mm in length; Grade B: nonconfluent mucosal breaks ≥ 5 mm in length; Grade C: confluent mucosal breaks \<75% circumferential; Grade D: confluent mucosal breaks \>=75% circumferential.
Number of Participants With Recorded Severity of Subjective Symptoms of Abdominal Bloating	Baseline, Month 6 and at Month 12	Presence or absence and severity of subjective symptoms were collected from participants during medical interviews of each visit as none (asymptomatic), mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), severe (unendurably symptomatic), and unknown. Number of participants who had mild, moderate, or severe abdominal bloating at each time points were reported.
Number of Participants With Recorded Severity of Subjective Symptoms of Nausea/Vomiting	Baseline, Month 6 and at Month 12	Presence or absence and severity of subjective symptoms were collected from participants during medical interviews of each visit as none (asymptomatic), mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), severe (unendurably symptomatic), and unknown. Number of participants who had mild, moderate, or severe nausea/vomiting at each time points were reported.
Number of Participants With Recorded Severity of Subjective Symptoms of Belching	Baseline, Month 6 and at Month 12	Presence or absence and severity of subjective symptoms were collected from participants during medical interviews of each visit as none (asymptomatic), mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), severe (unendurably symptomatic), and unknown. Number of participants who had mild, moderate, or severe belching at each time points were reported.
Number of Participants With Recorded Severity of Subjective Symptoms of Anorexia	Baseline, Month 6 and at Month 12	Presence or absence and severity of subjective symptoms were collected from participants during medical interviews of each visit as none (asymptomatic), mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), severe (unendurably symptomatic), and unknown. Number of participants who had mild, moderate, or severe anorexia at each time points were reported.
Number of Participants With Recorded Severity of Subjective Symptoms of Epigastric Burning	Baseline, Month 6 and at Month 12	Presence or absence and severity of subjective symptoms were collected from participants during medical interviews of each visit as none (asymptomatic), mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), severe (unendurably symptomatic), and unknown. Number of participants who had mild, moderate, or severe epigastric burning at each time points were reported.

Countries

Japan

Participant flow

Recruitment details

Participants took part in the survey at 122 investigative sites in Japan, from 01 March 2016 to 31 August 2018.

Pre-assignment details

Participants with a historical diagnosis of reflux esophagitis were enrolled. Participants received vonoprazan as part of a routine medical care.

Participants by arm

Arm	Count
Vonoprazan 10 mg or 20 mg Usually, for adults, 10 mg of vonoprazan administered orally once daily. If that dosing proved insufficient, the dosage may have been increased up to 20 mg once daily. Participants received vonoprazan as part of a routine medical care.	1,174
Total	1,174

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Case Report Forms Uncollected	9
Overall Study	Protocol Deviation	54

Baseline characteristics

Characteristic	Vonoprazan 10 mg or 20 mg	—
Age, Continuous	67.8 Years STANDARD_DEVIATION 13.6	—
BMI	23.17 Kilogram (kg)/meter (m)^2 STANDARD_DEVIATION 3.862	—
Drinking Habits No	701 Participants	—
Drinking Habits Unknown	317 Participants	—
Drinking Habits Yes	156 Participants	—
Duration of Diagnosis of Reflux esophagitis	1109.5 Days STANDARD_DEVIATION 1449.98	—
Endoscopic Findings Grade M	205 Participants	—
Endoscopic Findings Grade N	130 Participants	—
Endoscopic Findings Unassessed	716 Participants	—
Healthcare Category Inpatient	28 Participants	—
Healthcare Category Outpatient	1146 Participants	—
Height	157.86 Centimeters (cm) STANDARD_DEVIATION 9.727	—
Helicobacter Pylori Infection Negative	664 Participants	—
Helicobacter Pylori Infection Positive	72 Participants	—
Helicobacter Pylori Infection Unknown	438 Participants	—
Medical Complications Had Medical Complications	780 Participants	—
Medical Complications Had No Medical Complications	394 Participants	—
Medical History of Esophageal Hiatal Hernia Had Esophageal Hiatal Hernia	425 Participants	—
Medical History of Esophageal Hiatal Hernia Had No Esophageal Hiatal Hernia	591 Participants	—
Medical History of Esophageal Hiatal Hernia Unknown	158 Participants	—
Predisposition to Hypersensitivity Had No Predisposition to Hypersensitivity	1045 Participants	—
Predisposition to Hypersensitivity Had Predisposition to Hypersensitivity	72 Participants	—
Predisposition to Hypersensitivity Unknown	57 Participants	—
Prior Treatment with Acid Suppressants Had No Prior Treatment with Acid Suppressants	214 Participants	—
Prior Treatment with Acid Suppressants Had Prior Treatment with Acid Suppressants	931 Participants	—
Prior Treatment with Acid Suppressants Unknown	29 Participants	—
Purpose of Acid Suppressants Treatment Curative Therapy for Reflux Esophagitis	325 Participants	—
Purpose of Acid Suppressants Treatment Maintenance Therapy for Reflux Esophagitis	606 Participants	—
Race and Ethnicity Not Collected	—	— Participants
Region of Enrollment Japan	1174 Participants	—
Sex: Female, Male Female	683 Participants	—
Sex: Female, Male Male	491 Participants	—
Smoking Classification Current Smoker	100 Participants	—
Smoking Classification Ex-Smoker	181 Participants	—
Smoking Classification Never Smoked	563 Participants	—
Smoking Classification Unknown	330 Participants	—
Weight	58.05 Kilograms (kg) STANDARD_DEVIATION 12.985	—

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	7 / 1,174
other Total, other adverse events	11 / 1,174
serious Total, serious adverse events	15 / 1,174

Outcome results

Primary

Percentage of Participants Who Had One or More Adverse Drug Reactions

An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to administered drug.

Time frame: Up to 12 months

Population: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.

Arm	Measure	Value (NUMBER)
Vonoprazan 10 mg or 20 mg	Percentage of Participants Who Had One or More Adverse Drug Reactions	2.30 Percentage of Participants

Secondary

Endoscopic Relapse Rate

Endoscopic relapse rate was defined as a percentage of participants who met the criteria of Grade A to D in the modified Los Angeles (LA) classification. The modified LA classification graded endoscopic findings as follows- Grade N: normal mucosa; Grade M: minimal changes to the mucosa, such as erythema and/or whitish turbidity; Grade A: non-confluent mucosal breaks \<5 mm in length; Grade B: nonconfluent mucosal breaks ≥ 5 mm in length; Grade C: confluent mucosal breaks \<75% circumferential; Grade D: confluent mucosal breaks \>=75% circumferential.

Time frame: From the initiation of the maintenance therapy to Month 12 (or discontinuation of the therapy), up to 12 months

Population: Efficacy assessment population, The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available.

Arm	Measure	Value (NUMBER)
Vonoprazan 10 mg or 20 mg	Endoscopic Relapse Rate	4.00 Percentage of Participants

Secondary

Number of Participants With Recorded Severity of Subjective Symptoms of Abdominal Bloating

Presence or absence and severity of subjective symptoms were collected from participants during medical interviews of each visit as none (asymptomatic), mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), severe (unendurably symptomatic), and unknown. Number of participants who had mild, moderate, or severe abdominal bloating at each time points were reported.

Time frame: Baseline, Month 6 and at Month 12